Actively Recruiting
Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities
Led by Jerod L Stapleton, PhD · Updated on 2026-02-23
300
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
J
Jerod L Stapleton, PhD
Lead Sponsor
U
University of Louisville
Collaborating Sponsor
AI-Summary
What this Trial Is About
Lung cancer is a leading cause of death, especially in rural areas like Kentucky where incidence and mortality rates are very high. This research evaluates a new lung cancer survivorship care program designed to improve quality of life, reduce stigma, and increase engagement with care among lung cancer survivors. The study is a randomized controlled trial comparing this program to an enhanced usual care approach, aiming to benefit rural survivors facing significant challenges. The trial compares two groups: one receives the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC), which is a tailored behavioral intervention focusing on patient-centered care, shared decision making, and motivational interviewing. The other group receives enhanced usual care, which includes standard care plus bibliotherapy and assessment. The study will include 300 lung cancer survivors recruited from ten oncology centers in Kentucky. Participants will be monitored over six months, with assessments at the start and end of this period. Researchers will measure changes in lung cancer quality of life using the FACT-L tool, as well as survivor engagement, symptom burden, psychological well-being, and behavior changes. The study also examines the impact of caregiver involvement and evaluates the cost-effectiveness of the new program. The total duration and follow-up are designed to capture important outcomes related to survivorship care.
CONDITIONS
Brief Title
Precision Lung Cancer Survivorship Care Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have been diagnosed with lung cancer
- Reside in a rural county as determined by a Rural Urban Continuum Code (RUC) of 4 or higher
- Be at least 18 years of age or older
- Be able to communicate effectively in English
You will not qualify if you...
- Have significant psychiatric disturbance that requires a higher level of care
- Have substance abuse/dependence that requires a higher level of care
- Are participating in another lung cancer survivorship care intervention
- Have previously participated in the Kentucky LEADS Lung Cancer Survivorship Care Program
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program or enhanced usual care to improve lung cancer quality of life and engagement.
Baseline visit and follow-up visits during the 6-month intervention period
Duration - Up to 6 months from baseline
Participants are monitored to assess changes in quality of life, symptom burden, psychosocial well-being, and behavior at 6 months post-baseline.
Follow-up visit at 6 months
Trial Site Locations
Total: 1 location
1
Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
J
Jerod L Stapleton, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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